Stem Cell Clinic

Saanich father dies of leukemia after battle to find mixed-race stem cell donor – Victoria News

By adminJune 12, 2020Stem Cell Treatment

A Saanich father who fought to grow the data bank of mixed-race stem cell donors has died of leukemia.

Jeremy Chow was diagnosed with acute myeloid leukemia in November 2018. While chemotherapy treatment worked and Jeremy entered remission, doctors advised that stem cell therapy would be the best possible treatment to eradicate the risk of returning cancer cells.

But when Jeremy and his wife Evelyn Chow began their quest to find a match, they learned there were virtually no donors in the national or worldwide registry who matched Jeremys genetic makeup a requirement for a successful stem cell transplant.

READ ALSO: In a fight against cancer, Victoria mans only stem cell match was his own donation

Ironically, Jeremy had applied to become a stem cell donor years earlier. When doctors searched the database they found one unusable match: his own donation. Shocked and saddened by the lack of options, the family spearheaded the Match4Jeremy campaign, organizing stem cell drives and raising awareness of the dire need for mixed race and Asian donors.

On Aug. 8, 2019, the family learned that Jeremys cancer had returned. But the Chows battle to find a match didnt slow down. They worked with the Otherhalf-Chinese Stem Cell Initiative to host an emergency stem cell drive in Vancouver that month.

Despite their tireless efforts, Jeremy did not recover from the second round of cancer. The father of two died on May 30 with his wife at his side.

On a GoFundMe page aimed at raising money for his daughters educations, family friend Jenny Leung says Jeremy fought hard and did it with grace, humour and a positive attitude.

READ ALSO: Stem cell donor with rare genetic makeup needed to save Saanich man after cancer returns

Jeremys priority was always being able to provide and take care of his family, Leung writes. He was so involved with his girls lives, from driving them to their extracurricular activities to attending school fairs, to braiding their hair and explaining to them the importance of a good education.

He was always looking for a way to care for those around him whether it meant sharing knowledge, offering a helping hand, or just being there in any way he could, she added. Jeremy was truly someone to look up to and although he was always supporting others, he rarely asked for anything in return.

While the Chow family fought for a match for Jeremy, their crusade for stem cell donors gained momentum when they realized just how dire the situation was for mixed-race and Asian Canadians. Only three per cent of the Canadian Blood Services stem cell registry is mixed race.

In March 2019, Jeremy spoke with Black Press Media.

If all of this goes well [and] I stay in remission, and the awareness is out there and other people sign up to be donors and other people are getting the help they need, then thats a win, he said.

Donations are being accepted via GoFundMe to support Jeremys family and his daughters future education.

READ ALSO: Victoria couple continues fight for increased diversity in Canadian stem cell registry

Do you have something to add to this story, or something else we should report on? Email:nina.grossman@blackpress.ca

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Saanich father dies of leukemia after battle to find mixed-race stem cell donor - Victoria News

Global Adipose Derived Stem Cell Therapy Market Research Report Industry Analysis, Size, Share, Growth, Trends and Forecast – Medic Insider

By adminJune 12, 2020Stem Cell Treatment

Market Study Report has launched a report on Adipose Derived Stem Cell Therapy Market that elucidates an in-depth synopsis of this business vertical over the forecast period. The report is inclusive of the prominent industry drivers and provides an accurate analysis of the key growth trends and market outlook in the years to come in addition to the competitive hierarchy of this sphere.

The research report on Adipose Derived Stem Cell Therapy market provides a granular assessment of this business vertical and includes information concerning the market tendencies such as revenue estimations, current remuneration, market valuation, and market size over the estimated timeframe.

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An overview of the performance assessment of the Adipose Derived Stem Cell Therapy market is enlisted. The document also comprises of crucial insights pertaining to the major industry trends and the expected growth rate of the said market. The study encompasses specifics related to the growth avenues as well as the restraining factors for this business space.

Major factors underlined in the Adipose Derived Stem Cell Therapy market report:

Considering the geographical landscape of the Adipose Derived Stem Cell Therapy market:

Adipose Derived Stem Cell Therapy Market Segmentation: North America, Europe, Asia-Pacific & Middle East and Africa.

A summary of the details offered in the Adipose Derived Stem Cell Therapy market report:

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An overview of the Adipose Derived Stem Cell Therapy market in terms of product type and application scope:

Product landscape:

Product types: Autologous Stem Cells and Allogeneic Stem Cells

Key parameters included in the report:

Application Spectrum:

Application segmentation: Therapeutic Application and Research Application

Specifics offered in report:

Additional information mentioned in the report:

Other insights regarding the competitive scenario of the Adipose Derived Stem Cell Therapy market:

Vendor base of Adipose Derived Stem Cell Therapy market: AlloCure, Tissue Genesis, Antria, Cellleris, Corestem, Celgene Corporation, Mesoblast, Cytori Therapeutics, Pluristem Therapeutics, Intrexon, Lonza, BioRestorative Therapies, Pluristem Therapeutics, iXCells Biotechnologies, Cyagen and Celltex Therapeutics Corporation

Key parameters as per the report:

Highlights of the report:

Key questions answered in the report:

For More Details On this Report: https://www.marketstudyreport.com/reports/global-adipose-derived-stem-cell-therapy-market-growth-status-and-outlook-2020-2025

Some of the Major Highlights of TOC covers:

Development Trend of Analysis of Adipose Derived Stem Cell Therapy Market

Marketing Channel

Market Dynamics

Methodology/Research Approach

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Global Adipose Derived Stem Cell Therapy Market Research Report Industry Analysis, Size, Share, Growth, Trends and Forecast - Medic Insider

COVID 19 to Lead the Sales of Myelofibrosis Treatment to Register Stellar Growth in the Next 10 Years – Cole of Duty

By adminJune 12, 2020Stem Cell Treatment

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

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The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

The global market for myelofibrosis treatment is segmented on basis of treatment type, end user and geography:

As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

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Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

Some of the key market players in the global myelofibrosis treatment market are Incyte Corporation, Novartis AG, Celgene Corporation, Mylan Pharmaceuticals Ulc., Bristol-Myers Squibb Company, Eli Lilly and Company, Taro Pharmaceuticals Inc., AllCells LLC, Lonza Group Ltd., ATCC Inc. and others.

Hair loss treatment: Exhausted all options? This procedure may just do the trick – Express

By adminJune 12, 2020Platelet Rich Plasma Injections

Hair loss comes in many forms but one of the leading causes is male pattern baldness. Male pattern baldness tends to accelerate with age and usually runs in the family. It also tends to be permanent. There are a host of natural remedies purporting to treat male pattern baldness but the evidence is often scant.

An alternative option is to pursue a more invasive procedure that is supported by promising evidence.

Platelet-rich plasma (PRP) has been shown to treat male pattern baldness in several studies.

PRP is a substance drawn from your blood and injected into your scalp that can purportedly help heal bodily tissues, including follicles from which your hairs grow.

PRP is extracted from your blood using a centrifuge-like mechanism that can separate the substance from your blood and increase the concentration of specific proteins that promote healing.

READ MORE:Coronavirus update: Have you suffered hair loss? You could be at risk of severe symptoms

As a result, it has been shown promise in treating conditions such as osteoarthritis, is the most common form of arthritis, but research suggests the benefits extend to promoting hair growth.

A study of 11 people with androgenic alopecia found that injecting two to three cubic centimetres of PRP into the scalp every two weeks for three months could increase the average number of follicles from 71 to 93 units.

This study is too small to be conclusive, but it shows that PRP may be able to help increase the number of hair follicles that can actively support healthy hair.

Another study of 10 people receiving PRP injections every two to three weeks for three months showed improvements in the number of hairs, the thickness of those hairs, and the strength of the hair roots.

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What's more, a recent study compared two groups of people using different hair treatments for six months.

One group of 20 used minoxidil and the other group of 20 using PRP injections.

Minoxidil is one of the main medications used to treat hair loss.

Thirty people finished the study and results showed that PRP performed much better for hair loss than Rogaine.

It is important to note that the study also found that your level of platelets can affect how well your own plasma works for hair loss.

A lower level of blood platelets may mean that PRP isnt as effective for you.

How does PRP promote hair growth

Researchers believe that PRP contains proteins that serve several main functions that are thought to help hair regrow.

These are:

If you do not want to pursue invasive procedures, wigs are a viable option.

Some wigs are available on the NHS, but you may have to pay unless you qualify for financial help.

There are two types of wigs to choose from but both come with pros and cons.

According to the NHS, synthetic wigs:

Real-hair wigs:

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Hair loss treatment: Exhausted all options? This procedure may just do the trick - Express

Bone Marrow Processing Systems Market : Industry Trends and Developments 2018 2025 – Cole of Duty

By adminJune 12, 2020Stell Cell Research

Bone marrow aspirationand trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.

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Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.

Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy. Japan and China are the biggest markets for harvesting systems in Asia Pacific.

Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.

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Bone Marrow Processing Systems Market : Industry Trends and Developments 2018 2025 - Cole of Duty

Verve Therapeutics Adds $63M to Edit Heart Attack Risk Out of Genes – Xconomy

By adminJune 12, 2020Stell Cell Research

XconomyBoston

Verve Therapeutics aims to use gene editing to address heart attacks by targeting the liver, not the heart. And it wants to make its edits inside the patient. The startups approach raises a lot of questions. Verve has some answers now, and it has raised $63 million to learn more.

The new financing announced Thursday was led by GV, the same investor that led the Cambridge, MA-based companys Series A round of funding last year. With the additional cash, Verve CEO Sekar Kathiresan says Verve could reach its first human tests of a gene-editing therapy in about three years.

High cholesterol and triglyceride levels in the blood are among the biggest risk factors for a heart attack. For some people, high levels of these types of fats are inherited. In a condition called familial hypercholesterolemia, a genetic defect makes it harder for these people to remove the bad form of cholesterol from their blood. No matter how much they do in terms of diet and exercise, they continue to have high cholesterol levels that raise the risk of a heart attack.

Low cholesterol levels can also be inherited. In rare cases, people have a genetic mutation that turns off the gene that leads to high levels of cholesterol, Kathiresan says. Verves research is built on the 15 years of genetic research that identified eight genes linked to heart health. Such research has led to the commercialization of drugs that block PCSK9, a protein that inhibits the bodys ability to clear the bad form of cholesterol. But these drugs must be taken chronically.

Gene editing is typically thought of as a way to correct a genetic mutation that causes a problem. Verve, instead, is trying to give patients a mutation that confers a benefitturning off the gene that leads to high levels of cholesterol and triglycerides. If it works, its a one-time treatment.

What youre left with is the gene turned off forever, Kathiresan says. Its durable, lifelong control of cholesterol.

The genetic alteration would be made in vivoinside the patientby messenger RNA (mRNA), which is a genetic blueprint that carries editing instructions, and a guide RNA that gets this editor to the target gene. But to make the intended edit, the two pieces of nucleic acid need to reach their destination intact. Some companies are employing viral delivery systems. Thats the approach taken by Editas Medicine (NASDAQ: EDIT) and Allergan, now a subsidiary of AbbVie (NYSE: ABBV). Their experimental in vivo gene-editing therapy for a form of Leber congenital amaurosis, an inherited form of blindness, is delivered to target cells in the eye via an engineered adeno-associated virus. In March, a Phase 1/2 study testing the experimental therapy, AGN-151587, dosed its first patient.

A gene-editing therapy delivered via an engineered virus stays in the patient for months, which increases the risk of edits beyond the intended target, Kathiresan says. Instead, Verve uses a lipid nanoparticle, which stays in the system for about 48 hours. Such particles have been shown to quickly migrate to the liver, where they are easily taken up by the cells of the organ, Kathiresan says. Once in those cells, the Verve therapy does its work to turn off the target gene.

Verve is conducting its research with two gene-editing tools, CRISPR and base editing. Kathiresan says in the past year the company has evaluated combinations of tools and targets to determine which offer the best shot at reducing cholesterol levels while posing the lowest risk. So far the company has conducted tests in mice and monkeys. Kathiresan expects Verve will select a lead candidate by the end of this year. After that, he anticipates 18 months of preclinical research to support an application seeking FDA permission to begin tests of the gene-editing therapy in humans. Kathiresan says the first clinical trial testing Verves gene-editing drug will enroll familial hypercholesterolemia patients.

To date, Verve says it has raised $123 million total. The company calls the latest financing a Series A2 round. Earlier investors ARCH Venture Partners, F-Prime Capital, and Biomatics Capital also participated. Besides adding to its initial round, the Series A2 boosted Verves valuation, Kathiresan says. The new round also adds Wellington Management and Casdin Capital, two so-called crossover investorsfirms that invest in both private and public companies.

Crossover investment is viewed as a sign a company is preparing for an IPO. Kathiresan acknowledges that his company will need to raise more cash down the road but says its too early to determine what form that financing will take. He is, however, preparing to talk more about what Verve has accomplished so far. Kathiresan is the scheduled keynote speaker on June 27 during the annual meeting of the International Society for Stem Cell Research, where he says hell discuss more details about Verves scientific findings.

Image: iStock/SergeyNivens

Frank Vinluan is an Xconomy editor based in Research Triangle Park. You can reach him at fvinluan@xconomy.com.

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Verve Therapeutics Adds $63M to Edit Heart Attack Risk Out of Genes - Xconomy

Autolus Therapeutics presents AUTO1 and AUTO3 data at the 2020 EHA25 Virtual Congress – BioSpace

By adminJune 12, 2020Adult Stem Cells

Pivotal AUTO1 study in adult ALL patients enrolling

Conference Call and Webcast to be held Friday, June 12, 2020 at 7:30 am EDT / 12:30 pm BST

LONDON, June 12, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced new data highlighting progress on its AUTO1 program, the companys CAR T cell therapy being investigated in the ongoing ALLCAR Phase 1 study of relapsed / refractory adult B-Acute Lymphocytic Leukemia (ALL), at the European Hematology Association EHA25 Virtual Congress beginning June 11.

AUTO1 in ALLAs of the data cut-off date of May 13, 2020, 19 patients had received AUTO1. AUTO1 was well tolerated, with no patients experiencing Grade 3 CRS. Three patients (16%) with high leukemia burden (>50% blasts) experienced Grade 3 neurotoxicity that resolved swiftly with the application of steroids. Of the 19 patients, 16 (84%) achieved MRD-negative CR. Two out of 16 patients received a transplant while in remission and CD19-negative relapse occurred in 3 (16%) patients. Durability of remissions is encouraging. Event Free Survival (EFS) and Overall Survival (OS) at 6 months are 62% and 72% respectively in all patients, and 76% and 92% respectively in the 13 patients treated with the closed (commercial) process. Median EFS and OS has not been reached, at a median follow up of 12.2 months (range up to 24.4 months).

I am very encouraged by the tolerable safety profile and high level of sustained CRs we have observed with AUTO1 in the ALLCAR19 study that was achieved without subsequent stem cell transplant, said Dr. Claire Roddie, Consultant Hematologist, UCL Cancer Institute and University College London Hospital.

Approximately 60% of adult ALL patients relapse or are refractory to first line therapy and there continues to exist a high unmet need, said Dr. Michael Bishop, MD, Professor of Medicine and Director of the Cellular Therapy Program at University of Chicago Medicine. AUTO1 is a novel CD19 CAR T candidate with a compelling activity and safety profile and has the potential to change standard of care as a curative therapy for r/r ALL.

The data update on AUTO1 presented at this years EHA meeting show an encouraging durability of response without subsequent stem cell transplant and confirm the positive safety profile, said Dr. Christian Itin, chairman and chief executive officer of Autolus. We have started enrolment of patients with r/r aALL in our pivotal Phase 1b/2 AUTO1-AL1 study.

AUTO3 in DLBCLDr. Wendy Osborne presented ALEXANDER Phase 1/2 clinical trial data for AUTO3. This data is consistent with our update on May 29, 2020, with a data cut-off date of April 27, 2020.

These data are very encouraging, in terms of safety and tolerability, with a high level of clinical activity, said Dr. Wendy Osborne, Consultant Hematologist, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust. We are looking forward to enrolling additional patients in the outpatient cohort.

Dr. Wendy Osborne of Newcastle upon Tyne Hospitals NHS Foundation Trust also discusses AUTO3 data during the American Society of Clinical Oncology (ASCO) Annual Meeting in this video courtesy of the Lymphoma Hub.

Investor call on Friday June 12, 2020Management will host a conference call and webcast at 7:30 am EDT/12:30 pm BST to discuss the EHA data. To listen to the webcast and view the accompanying slide presentation, please go to: https://www.autolus.com/investor-relations/news-and-events/events.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 4838626. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 4838626.

About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com.

About AUTO1 AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL. The company has also now progressed the program to a potential pivotal study, AUTO1-AL1.

About AUTO1-AL1 pivotal studyThe AUTO1-AL1 study will enroll patients with relapsed / refractory ALL. The study will have a short Phase1b component prior to proceeding to a single arm Phase 2 study. The primary end point is overall response rate and the key secondary end points include duration of response MRD negative CR rate and safety. The study will enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the US, UK and Europe.

About AUTO3AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in diffuse large B cell lymphoma in the ALEXANDER clinical trial, with a 20-patient cohort that was initiated in Q2 2020 to assess feasibility of treatment in an outpatient setting.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, including its expected cash runway; the development of Autolus product candidates, including statements regarding the timing of initiation, completion and the outcome of pre-clinical studies or clinical trials and related preparatory work, and the periods during which the results of the studies and trials will become available; Autolus plans to research, develop, manufacture and commercialize its product candidates; the potential for Autolus product candidates to be alternatives in the therapeutic areas investigated; and Autolus manufacturing capabilities and strategy. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 3, 2020 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Lucinda Crabtree, PhDVice President, Investor Relations and Corporate Communications+44 (0) 7587 372 619l.crabtree@autolus.com

Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

Susan A. NoonanS.A. Noonan Communications+1-212-966-3650susan@sanoonan.com

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Autolus Therapeutics presents AUTO1 and AUTO3 data at the 2020 EHA25 Virtual Congress - BioSpace

Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with Multi…

By adminJune 12, 2020Adult Stem Cells

Copenhagen, Denmark; June 4, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), has been approved in the U.S. for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with Multi...

Canine Stem Cell Therapy Market to Expand with Significant CAGR – WorldsTrend

By adminJune 12, 2020Stem Cell Clinics

Health care stakeholders need to invest in value-based care, innovative care delivery models, advanced digital technologies. XploreMR will help you to know declarative, procedural, contextual, and somatic information about the Canine Stem Cell Therapy Market. It also provides a critical assessment of the performance of emerging and mature markets in a new publication titled Global Market Study on Canine Stem Cell Therapy: Ongoing Clinical Trials and Focus on Advancements to Push Adoption in Veterinary Clinics.

A synopsis of the global canine stem cell therapy market with reference to the global healthcare pharmaceutical industry

Despite the economic and political uncertainty in the recent past, the global healthcare industry has been receiving positive nudges from reformative and technological disruptions in medical devices, pharmaceuticals and biotech, in-vitro diagnostics, and medical imaging. Key markets across the world are facing a massive rise in demand for critical care services that are pushing global healthcare spending levels to unimaginable limits.

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A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry. Proactive measures such as healthcare cost containment, primary care delivery, innovation in medical procedures (3-D printing, blockchain, and robotic surgery to name a few), safe and effective drug delivery, and well-defined healthcare regulatory compliance models are targeted at placing the sector on a high growth trajectory across key regional markets.

Parent Indicators Healthcare

Research Methodology

XploreMR utilizes a triangulation methodology that is primarily based on experimental techniques such as patient-level data, to obtain precise market estimations and insights on Molecule and Drug Classes, API Formulations and preferred modes of administration. Bottom-up approach is always used to obtain insightful data for the specific country/regions. The country specific data is again analysed to derive data at a global level. This methodology ensures high quality and accuracy of information.

Secondary research is used at the initial phase to identify the age specific disease epidemiology, diagnosis rate and treatment pattern, as per disease indications. Each piece of information is eventually analysed during the entire research project which builds a strong base for the primary research information.

Primary research participants include demand-side users such as key opinion leaders, physicians, surgeons, nursing managers, clinical specialists who provide valuable insights on trends and clinical application of the drugs, key treatment patterns, adoption rate, and compliance rate.

Quantitative and qualitative assessment of basic factors driving demand, economic factors/cycles and growth rates and strategies utilized by key players in the market is analysed in detail while forecasting, in order to project Year-on-Year growth rates. These Y-o-Y growth projections are checked and aligned as per industry/product lifecycle and further utilized to develop market numbers at a holistic level.

On the other hand, we also analyse various companies annual reports, investor presentations, SEC filings, 10k reports and press release operating in this market segment to fetch substantial information about the market size, trends, opportunity, drivers, restraints and to analyse key players and their market shares. Key companies are segmented at Tier level based on their revenues, product portfolio and presence.

Please note that these are the partial steps that are being followed while developing the market size. Besides this, forecasting will be done based on our internal proprietary model which also uses different macro-economic factors such as per capita healthcare expenditure, disposable income, industry based demand driving factors impacting the market and its forecast trends apart from disease related factors.

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Standard Report Structure

Target Audience

Market Taxonomy

The global canine stem cell therapy market has been segmented into:

Product Type:

Application:

End User:

Region:

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Canine Stem Cell Therapy Market to Expand with Significant CAGR - WorldsTrend

Human Embryonic Stem Cells Market Size Detailed Analysis …

By adminJune 12, 2020Embryonic Stem Cells

The MarketWatch News Department was not involved in the creation of this content.

Jun 08, 2020 (Market Insight Reports) --Selbyville, Delaware, Global Human Embryonic Stem Cells Market Report added at Market Study Report LLC offers industry size, share, growth, trends and forecast analysis up to 2026. Human Embryonic Stem Cells Market Report also covers top key players, porters five forces analysis and market segmentation in detail. This report examines the global Human Embryonic Stem Cells market and provides information regarding the revenue for the period 2020 to 2026.

Due to COVID-19 pandemic, the market is facing challenges because of government protocols to stay at home across the world. Human Embryonic Stem Cells (hESCs) are derived from blastocyst and are capable of differentiating into number of cell types that make up the human body as well as it replicates indefinitely and produce non-regenerative tissues such as neural and myocardial cells.

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They are used in treating a number of blood and genetic disorders related to the immune system, cancers, and disorders as well as used in investigational studies of early human development, genetic diseases and toxicology testing. The technological advancement involving stem cells therapy, rising demand for regenerative medicines, R&D in toxicology testing, technological advancements for the production of embryonic stem cells through alternative methods and increasing prevalence of genetic disorders are the few factors responsible for growth of the market over the forecast period.

Furthermore, the introduction of innovative products and other strategic advancements by market players will create lucrative opportunities for the market. For instance, as per company's news release in January 2019, Stemcell Technologies Inc. launched mTeSR(TM) Plus, an enhanced version of mTeSR(TM)1. mTeSR(TM) Plus is the stabilized feeder-free maintenance medium for human embryonic stem (ES) and induced pluripotent stem (iPS) cells. However, ethical concern related to stem cell research is the major factor restraining the growth of global Vegetable Chips market during the forecast period.

Major market player included in this report are:

The regional analysis of global Human Embryonic Stem Cells market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. Asia Pacific is the leading/significant region across the world due to the presence of several prominent entities incorporated in the U.S. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2020-2026.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players.

By Region:

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Global Human Embryonic Stem Cells (HESC) Market Size, Status and Forecast 2025

This report studies the global Human Embryonic Stem Cells (HESC) market size, industry status and forecast, competition landscape and growth opportunity. This research report categorizes the global Human Embryonic Stem Cells (HESC) market by companies, region, type and end-use industry.

https://www.marketstudyreport.com/reports/global-human-embryonic-stem-cells-hesc-market-size-status-and-forecast-2025?utm_source=MarketwatchTM.com/&utm_medium=SP

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